Hydroxyurea

Product NDC: 68084-284
11-digit product format: 680840284
Labeler code: 68084
Product ID: 68084-284_4c118bb8-d003-3029-e063-6394a90a7d36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyurea
Dosage form: CAPSULE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA075340
Marketing category: ANDA
Marketing start: 2008-09-17
Substance: HYDROXYUREA
Active strength: 500 mg/1
Pharmacologic classes: Antimetabolite [EPC], Urea [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075340-001	HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE / ORAL	AB		1999-02-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075340-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075340-001	HYDROXYUREA	500MG	CAPSULE / ORAL	AB	1999-02-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075340-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075340-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075340-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075340-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075340-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075340-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075340-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075340-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075340-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075340-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075340-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075340-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075340-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075340-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075340-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075340-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075340-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075340-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075340-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075340-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075340-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075340-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075340-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075340-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075340-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075340-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075340-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075340-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075340-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075340-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075340-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075340-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075340-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075340-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075340-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075340-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075340-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075340-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075340-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075340-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydroxyurea
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYUREA	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X6Q56QN5QC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197797	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c84a2241-6c05-480f-8a5b-049e08c27d73	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9be3ebe6-89e5-4e2f-8781-a389e7eb49e7	Product name	1	20250129
f76fb619-09b6-d149-3287-3661f7bc38cd	Product name	3	20250124
62a0eedf-9497-47af-bccf-d51b8b15b067	Product name	1	20180307

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-284-01	Hydroxyurea	100 in 1 BOX, UNIT-DOSE	CAPSULE	100		12
68084-284-11	Hydroxyurea	1 in 1 BLISTER PACK	CAPSULE	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-284-01	EA - Each	68084-284	80ad38e9-b735-43be-ba9f-eb7d30d7a045	1	2012-07-24
68084-284-11	EA - Each	68084-284	6ac196b2-dc16-4bd9-920d-030b181ccd4d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYUREA	ACTIVE INGREDIENT	X6Q56QN5QC	HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING]	3
HYDROXYUREA	ACTIVE MOIETY	X6Q56QN5QC	HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-284	HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING]	11	Current NDC, Legacy NDC, 2 package rows	20240919_c84a2241-6c05-480f-8a5b-049e08c27d73.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyurea	HYDROXYUREA	Major Pharmaceuticals	e76fd60e-7644-48c5-9857-3608a045000b	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075340 application number: ANDA075340
Hydroxyurea	HYDROXYUREA	Par Health USA, LLC	9e1bdd4b-043a-4cf6-b1ff-8de49e02b7a6	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075340 application number: ANDA075340
Hydroxyurea	HYDROXYUREA	American Health Packaging	c84a2241-6c05-480f-8a5b-049e08c27d73	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075340 application number: ANDA075340 ndc (product): 68084-284

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X6Q56QN5QC	HYDROXYUREA	127-07-1	HYDROXYUREA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197797	hydroxyurea 500 MG Oral Capsule	PSN	c84a2241-6c05-480f-8a5b-049e08c27d73	12
197797	hydroxyurea 500 MG Oral Capsule	SCD	c84a2241-6c05-480f-8a5b-049e08c27d73	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-284-01	68084028401	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-284-01) / 1 CAPSULE in 1 BLISTER PACK (68084-284-11)	100 blister pack	2008-09-17	0000-00-00	No	No	Current
68084-284-11	68084028411	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyurea	American Health Packaging	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	12
Hydroxyurea	Cardinal Health 107, LLC	2024-09-23	HUMAN PRESCRIPTION DRUG LABEL	8